Prolgolimab Approved Naked monospecific

Antibody Information

Entry ID	31
INN	Prolgolimab
Status	Approved
Drug code(s)	BCD-100
Brand name	Forteca
mAb sequence source	mAb chimeric
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	Vlambda-Ckappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	PD-1
Indications of clinical studies	Non-small cell lung cancer, Melanoma, Solid tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved Russia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	September 15, 2016
Start of Phase 2
Start of Phase 3	August 31, 2017
Date BLA/NDA submitted to FDA
Year of first approval (global)	2020
Date of first US approval
INN, US product name	Prolgolimab
US or EU approved indications	None

Company information

Company	Biocad
Licensee/Partner	None
Comments about company or candidate	April 27, 2020: The first Russian original PD-1 inhibitor Forteca® (INN: prolgolimab) was granted approval for market authorization by the Russian Ministry of Health for the treatment of one of the most aggressive types of cancer -- unresectable or metastatic melanoma. The approval is based on the positive clinical results from a multicenter open-label parallel-arm phase II study MIRACULUM (NCT03269565) in patients with advanced melanoma. EudraCT Number 2018-004791-36 (BCD-100-3/DOMAJOR) started in Hungary and Slovakia in Sep 2019. NCT03912389 (DOMAJOR; NSCLC) and NCT03912415 (cervical cancer) Phase 3 studies not yet recruiting; last updated in May 2019. Conclusions from Phase 2 NCT03269565 study in melanoma: Both dosing regimens of BCD-100 (1 mg/kg Q2W and 3 mg/kg Q3W) have durable antitumor activity and a manageable safety profile in patients with advanced melanoma. (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.9549?af=R) Phase 2/3 study started Aug 31, 2017 still recruiting as of Aug 1, 2018. Phase 2/3 in NSCLC recruiting as of Oct 2017. NCT03050047 Phase 1. Innovative molecule according to Biocad
Full address of company	198515, Saint Petersburg, Intracity Municipality the Settlement of Strelna, ul. Svyazi, d. 38, str. 1, pomeshch. 89 Europe Russia https://biocadglobal.com/contacts

Description/comment

Immune checkpoint target. Immunoglobulin G1_V-lambda-C-kappa. BCD-100 is an IgG1 anti-PD-1 monoclonal antibody with Fc silencing “LALA” mutation. (https://abstracts.asco.org/239/AbstView_239_267653.html). Sequence found in patent (https://patents.google.com/patent/RU2656181C1/en)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None